Monofilament implants and systems for delivery thereof

ABSTRACT

Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient&#39;s vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.

RELATED APPLICATIONS

This application is a continuation of and claims priority toInternational Patent Application No. PCT/IL2013/050981, filed Nov. 27,2013, and entitled “Monofilament Implants and Systems for DeliveryThereof,” which in turn claims priority to U.S. Provisional PatentApplication No. 61/754,264, filed Jan. 18, 2013, entitled “MonofilamentImplants and Systems for Delivery Thereof.”This application also claimspriority to pending U.S. patent application Ser. No. 14/552,890, filedNov. 25, 2014, entitled “Systems, Methods and Devices for EmbolicProtection,” which in turn is a continuation of and claims priority toInternational Patent Application No. PCT/IB2013/001336, filed May 30,2013, and entitled “Systems, Methods and Devices for EmbolicProtection,” which in turn claims priority to U.S. Provisional PatentApplication No. 61/653,676, filed May 31, 2012, and entitled “Apparatusand Methods of Providing Embolic Protection in a Patient,” U.S.Provisional Patent Application No. 61/693,979, filed Aug. 28, 2012, andentitled “Apparatus and Method of Providing Embolic Protection in a BodyVessel of a Patient,” U.S. Provisional Patent Application No.61/746,423, filed Dec. 27, 2012, and entitled “Apparatus and Method ofProviding Embolic Protection in a Body Vessel of a Patient,” and U.S.Provisional Patent Application No. 61/754,264, filed Jan. 18, 2013, andentitled “Monofilament Implants and Systems for Delivery Thereof” Thepresent application incorporates herein by reference the disclosures ofeach of the above-referenced applications in their entireties.

FIELD OF THE DISCLOSURE

Embodiments of the present disclosure are directed generally tomonofilament medical implants, and systems and methods for theirdelivery. Some embodiments of said systems may be automatic. Someembodiments are directed to embolic protection devices, and systems andmethods for the delivery thereof. Some of the embodiments are directedat preventing embolic stroke.

BACKGROUND OF THE DISCLOSURE

Expandable implantable devices are often used for opening and closingpassageways or orifices within the vascular, urinary, orgastrointestinal (GI) systems. Examples include vascular and GI stentsfor opening occlusions, left atrial appendage (LAA) and patent foramenovale (PFO) occluding devices, and others. Such implantable devicestypically consist of a scaffold that is introduced in a collapsed stateand is expanded to a desired configuration at a target organ.

U.S. Provisional Patent Application 61/746,423, filed Dec. 27, 2012, toYodfat and Shinar, assigned to Javelin Medical Ltd., disclosesexpandable devices and a method for implanting the devices within thebody. Some of the embodiments of that disclosure are directed to devicesmade of super-elastic metal (e.g., nitinol) configured into amonofilament which is spatially bent and/or twisted (e.g., upondelivery). Such devices have two operating states—a contracted state(undeployed) and an expanded state (deployed). The devices may beimplanted using a delivery system comprising (for example) a rigidneedle having a preferred diameter of <1 mm (3 French, 0.04″) and asharp distal end. The devices may be preassembled within the needle intheir stretched, substantially-linear, undeployed state and positionedat the needle's distal end. A pusher, in the form of an elongated rod,may also be preassembled within the needle, extending from proximally tothe proximal end of the needle to the proximal end of the device. Theimplantation of the device may be performed by piercing the skin andunderlying tissues and advancing the needle to the target organ underultrasound guidance. At the desired location, the device may beexteriorized by retracting the needle with respect to the patient,pushing the pusher with respect to the patient, or both. This createsrelative motion between the needle and the pusher, thereby exteriorizingthe device. During the exteriorization process the device assumes itsexpanded deployed state within the target.

In a preferred embodiment, the device may be used as a filtering device(hereinafter “filtering device” or “embolic protection device”) forcardio-embolic stroke prevention. Such devices may be implanted at bothcarotid arteries to protect the brain from emboli originating in theheart, aorta, or other proximal large vessels.

The deployed state of the stroke prevention filtering device, accordingto those disclosed embodiments, may have the shape of a helical springroughly occupying a spherical shell, with straight short ends extendingfrom each side of the helix at the in the direction of the helix'sprincipal axis of symmetry. Anchors for securing the filtering device tothe carotid walls may reside at both ends. The anchors may also be maderadiopaque or echogenic to provide visibility. When deployed, the deviceresides in transverse orientation within carotid artery lumen, the twodevice ends pierce the artery walls, and both anchors reside externallyto lumen.

In the undeployed state, the device according to some embodiments,including anchors, resides within the lumen of the needle. The distalanchor is connected to the distal end of the helical spring and residesat distal end of the needle. The proximal anchor may be connected to theproximal end of the helical spring and reside closer to the proximal endof the needle than to the distal end of the device. After deployment,the anchors may self-expand to their deployed state.

Implantation, according to some embodiments, comprises insertion of theneedle with the preassembled filtering device through the skin of theneck and transversally bisecting the carotid artery. Subsequently, theneedle is retracted and the filtering device is exteriorized by thepusher. The filtering device assumes its deployed shape and is anchoredexternally to the carotid wall at both ends.

Experience shows that when the device is exteriorized from the needle,its distal end, at times, may rotate, bend, or twist. Therefore,whenever the device is exteriorized after its distal end is anchored inthe carotid wall, this tendency to rotate, bend, or twist creates torqueon the anchor. Accordingly, such torque might damage the tissuesurrounding the anchor. Alternatively, the anchor may remain motionlessbut torsion may accumulate in the monofilament component of the device,thereby preventing it from assuming the desired deployed helical shape:The windings of the helix may distort and cross over.

Thus, there is a need for a helical filtering device that can beinserted into the carotid arteries in a safe and reproducible manner.

There is also a need to provide a helical filtering device that cantransition from a helical shape to a substantially linear shape andback, without plastically deforming.

There is also a need for a helical filtering device (or any othermonofilament device) in which torsion does not accumulate duringdeployment.

There is also a need for a helical filtering device (or any othermonofilament device) comprising at least one bearing.

There is also a need for a system and method for safe implantation of amonofilament helical filtering device (or any other monofilament device)such that damage to the vessel walls and surrounding tissues is avoided.

There is also a need to provide a system for automatically implanting afiltering device (or any other monofilament device) in a safe andreproducible manner.

There is also a need to provide a system for automatically implanting afiltering device (or any other monofilament device) using a single hand.

There is also a need to provide a system for implanting a filteringdevice (or any other monofilament device), the system including housingand a user interface.

There is also a need for a system for implanting a filtering device (orany other monofilament device), the system including one or moresensors. Sensors may provide an indication of the needle position withinthe body or an indication of the deployment status or progression.

There is also a need for a system for implanting a filtering device (orany other monofilament device) that prevents the build-up of torsion inthe filtering device by synchronizing device exteriorization and devicerotation, bending, or twisting.

There is also a need for a system for implanting a filtering device (orany other monofilament device) that prevents the build-up of torsion inthe filtering device by synchronizing device exteriorization and devicerotation, bending, or twisting, wherein the system comprises a powersupply, a motor, a controller, a driving mechanism, a sensor, and a userinterface.

SUMMARY OF THE DISCLOSURE

In some embodiments, the filtering device is a monofilament made of asuper-elastic alloy (i.e. nitinol), and has a circular cross section. Inthe deployed state the device is shaped as a helix (coil, spring, ortheir like) tracing a spherical shell, with two straight shortmonofilament segments extending from each helix end. The segments areoriented substantially collinear with the helix's principal axis ofsymmetry.

In some embodiments, each end-segment may comprise an end piece. Eachend piece may comprise one or more of a radiopaque marker, an echogenicmarker, an anchor, and/or a bearing. The bearing may have an axle, whichmay be integral with the monofilament, and housing. The axle may freelyrotate within the housing, thereby eliminating the build-up ofdeleterious torsion during device deployment.

some embodiments, in the undeployed state, the helix-shaped monofilamentis stretched to a substantially linear shape and assembled within thelumen of a needle. The distal end piece resides at the distal sharp endof the needle and proximal end piece resides closer to the proximal endof needle than the distal end of the device. A straight rod (“pusher”)is assembled within proximal side of needle; the pusher distal end is incontact with the proximal end of the filtering device.

In some embodiments, implantation comprises insertion of the needle,with the filtering device preassembled, through the neck skin, andtransversally bisecting the carotid artery. Subsequently, retraction ofneedle and/or pusher advancement exteriorize the filtering device fromneedle may be according to the following sequence:

-   -   1—The distal end piece is deployed externally to carotid lumen        and anchored within surrounding tissue. The end piece may        comprise a bearing enabling free rotation of the bearing axle        around longitudinal axis, thereby avoiding the build-up of        torsion in the monofilament.    -   2—The helical monofilament is deployed within the carotid lumen.        During deployment the helix rotates roughly around its axis of        symmetry, with distal end of the helix (axle) serving as a pivot        point.    -   3—The proximal end piece is deployed externally to proximal side        (close to skin) of the carotid lumen.

In some embodiments, torsion release may be achieved by concomitantneedle retraction, needle rotation, and pusher advancement duringfiltering device exteriorization.

In some embodiments, implantation of the filtering device (or any othermonofilament device) may be performed using a system that automaticallysynchronizes needle retraction, filtering device exteriorization,filtering device rotation, bending, or twisting (and correspondingtorsion build-up prevention or release) during filtering deviceimplantation. The system may comprise housing, a power supply, a motor,a control unit, and a driving mechanism. In some embodiments, the systemcomprises a reusable element. The needle and filtering device(disposables) may be pre-assembled before insertion and the needle isdisposed after use. The driving mechanism may comprise gears that areengaged with proximal ends of the needle and the pusher. Upon operatoractivation, the controller operates a motor, synchronizes the needleand/or pusher rotation, and needle retraction. The system may includeuser interface components (operating buttons, screen, etc.), sensors(i.e. pressure sensor for safe positioning of needle end within artery),and indication means for providing better operator control duringinsertion.

Advantages of Some of the Embodiments

Embodiments according to the present disclosure have several importantadvantages over prior art:

Various embodiments of filtering devices according to the presentdisclosure may be safely inserted by providing a mechanism to preventthe build-up of torsion or to release accumulated torsion within thedevice.

Various embodiments of monofilament device implantation systemsaccording to the present disclosure may provide safe and reproducibledevice implantation by automatically executing any combination of thefollowing motions: needle retraction, needle advancement, deviceretraction, device advancement, device rotation, device bending, ordevice twisting. In particular, the build-up of torsion in the devicemay be prevented, and accumulated torsion may be released.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood with reference to theaccompanying drawings and subsequently provided detailed description:

FIG. 1A depicts the undeployed state of a monofilament filtering deviceaccording to some embodiments of the present disclosure.

FIG. 1B depicts the deployed (helical) state of the monofilamentfiltering device of FIG. 1A.

FIG. 2A depicts the undeployed state of a monofilament filtering devicecomprising end pieces according to some embodiments of the presentdisclosure.

FIG. 2B depicts the undeployed state of a monofilament filtering devicecomprising end pieces according to some embodiments of the presentdisclosure.

FIG. 3A depicts a schematic rendering of the undeployed state of an endpiece according to some embodiments of the present disclosure.

FIG. 3B depicts a schematic rendering of the deployed state of an endpiece according to some embodiments of the present disclosure.

FIG. 4A depicts the undeployed state of an end piece according to someembodiments of the present disclosure.

FIG. 4B depicts the deployed state of an end piece according to someembodiments of the present disclosure.

FIG. 5A depicts the undeployed state of another end piece according tosome embodiments of the present disclosure.

FIG. 5B depicts the deployed state of another end piece according tosome embodiments of the present disclosure.

FIGS. 6A-6E depict an apparatus and method according to some embodimentsof the present disclosure, which are intended for implanting amonofilament filtering device according to some embodiments of thepresent disclosure.

FIG. 7 is a block diagram of an automatic system according to someembodiments of the present disclosure, which is intended for implantinga monofilament filtering device (or any other monofilament device)according to some embodiments of the present disclosure.

FIG. 8 is a schematic representation of an automatic system according tosome embodiments of the present disclosure, which is intended forimplanting a monofilament filtering device (or any other monofilamentdevice) according to some embodiments of the present disclosure.

FIG. 9A depicts a perpendicular cross section of a needle of anautomatic system of some embodiments of the present disclosure.

FIG. 9B depicts a perpendicular cross section of an end-piece of afiltering device (or any other monofilament device) according to thepresent disclosure.

FIGS. 10A and 10B depict a monofilament filtering device according tosome embodiments of the present disclosure in operation.

DETAILED DESCRIPTION OF SOME OF THE EMBODIMENTS

Reference is now made to FIG. 1A, which depicts some embodiments of theundeployed state of a filtering device (embolic protection device) ofthe present disclosure. Filtering device 10, configured to be implantedin a body vessel, can be a filament of cylindrical shape. However, crosssectional shapes other than circular are also possible.

In some embodiments, the length of the filament from which filteringdevice 10 is made may be greater than the diameter of the body vesselfor which it is intended. Thus, if implanting the filtering device in avein or an artery having a diameter of 7 mm, then the length of thefilament may be, for example, in the range of about 7 to about 300 mm.

In some embodiments, the diameter of the filament from which filteringdevice 10 is made may be substantially less than its length. Forimplantation into a blood vessel, the filament diameter may be chosen ofa size sufficient so as to not to cause blood coagulation. Therefore,the filament diameter, according to some embodiments, is less than about0.5 mm, and more specifically less than about 0.2 mm, and even morespecifically, less than about 0.15 mm.

In some embodiments, the undeployed state of device 10 may assume anyshape that fits within the lumen of a tube having a length L and aninner diameter D such that L is much greater than D. (the terms“substantially linear” or “substantially straight” as used herein referto all such shapes.) For example, length L can be in the range of about10 to about 300 mm, whereas the diameter D can be in the range of about0.05 to about 0.7 mm.

In some embodiments, the undeployed state of device 10 may assume, forexample, the shape of a substantially straight line. It may also assumea shape resembling a helix in which the pitch (that is, the verticaldistance between consecutive windings) may be much larger than the helixdiameter (that is, the diameter of the smallest cylinder in which thehelix might fit).

Reference is now made to FIG. 1B, which depicts an embodiment of thedeployed state of a filtering device of the present disclosure. In thedeployed state, filtering device 10 may assume the shape of a coil or aspring (helix). This coil shape may have windings or turns that vary indiameter. The windings may approximately trace the shape of a sphericalshell.

The deployed length L′ of filtering device 10 may be greater than thediameter of the body vessel for which it is intended. Thus, ifimplanting the filtering device in a vein or an artery having a diameterof about 7 mm, then the deployed length L′ can be, for example, in therange of about 7 to about 20 mm. The deployed diameter D′ of filteringdevice 10 may be less than or approximately equal to the diameter of thetarget vessel at the implantation site. For example, if implanting thefiltering device in a vein or an artery having a diameter of about 7 mmthen the diameter D′ may be in the range of about 5 mm to about 8 mm.

In the deployed state, the “north-south” axis connecting distal end 11and proximal end 12 of device 10 is substantially perpendicular to theplane approximately defined by some of the spring windings. The distalsegment 13 and the proximal segment 14 of device 10 may be substantiallycollinear with the north-south axis.

The distal turn 15 of device 10 may reside in a plane containing thenorth-south axis. Likewise, the proximal turn 16 in device 10 may alsoreside in a plane containing the north-south axis. The two planes may,but do not have to, be one and the same. All of the remaining turns indevice 10 may reside in planes that are approximately, but notnecessarily exactly, perpendicular to the north-south axis.

Device 10 may be configured such that in the deployed state the radiusof curvature at any point along its length is greater than or equal to acritical value R_(c). This critical value may be assigned such that thestrain suffered at any point of device 10 is less than or equal to thecritical strain required to bring about an elastic-to-plastictransformation. In this way device 10 may be able to suffer a transitionfrom the deployed shape to the undeployed shape and back withoutsubstantial difference between the initial and final deployed shapes.For example, if the filament from which device 10 is made has a circularcross section having diameter d, and the material from which device 10is made has critical strain ε, then the critical value R_(c) may begiven by R_(c)=d/2ε. Therefore, if, for example, device 10 is made fromsuper-elastic nitinol having critical strain £ of about 0.08, and thefilament diameter d is about 0.15 mm, then the critical radius ofcurvature will be roughly about 0.94 mm.

The deployed state of device 10 may be configured to trap embolicmaterial having typical size that is larger than the distance δ betweenconsecutive windings. Whenever device 10 is configured to protect apatient from major embolic stroke, device 10 is made to trap emboliexceeding about 1-2 mm in size. In this case the distance δ is less thanabout 1.5 mm, and, more specifically, in the range of about 0.7 mm andabout 1.5 mm.

Filtering device 10 may be configured to be relatively stiff or, in someembodiments, relatively flexible. Alternatively, filtering device 10 maybe configured to assume any degree of flexibility. In the deployedshape, filtering device 10 may possess either a low spring constant or ahigh spring constant. Alternatively, in the deployed state, filteringdevice 10 may be configured to any value for its corresponding springconstant.

Filtering device 10, according to some embodiments, can be configured asa solid filament. Alternatively, it can be configured as a tube having ahollow lumen, or as a tube having its ends closed-off, thereby leavingan elongated air-space inside filtering device 10. Leaving an air-spaceinside filtering device 10 may have the advantage of making filteringdevice 10 more echogenic and therefore more highly visible by ultrasoundimaging. Filtering device 10 may possess an echogenic marker or aradiopaque marker.

Filtering device 10 can be made out of any suitable biocompatiblematerial, such as metal, plastic, or natural polymer. Suitable metalsinclude shape-memory alloys and super-elastic alloys (nitinol). Suitablepolymers may include shape memory polymers or super-elastic polymers.

A filtering device according to some embodiments of the presentdisclosure is substantially similar to filtering device 10, except forone or more of the following differences: part or all of distal segment13 may be lacking, part or all of distal turn 15 may be lacking, part orall of proximal segment 14 may be lacking, and part or all of proximalturn 16 may be lacking. For example, a filtering device substantiallysimilar to 10 but lacking distal segment 13 and distal turn 15 may beparticularly suitable for implantation through a single puncture in atarget vessel. In such an embodiment, all device parts except perhapsfor proximal segment 14 may lie entirely inside the vessel lumen orwalls. Distal end 11 may comprise a non-traumatic tip, or a short, sharpend configured to anchor in the vessel wall without breaching itcompletely.

Reference is now made to FIGS. 2A and 2B, which respectively representthe undeployed and the deployed states of another embodiment of thefiltering device of the present disclosure. Filtering device 20 issubstantially similar to filtering device 10 of FIGS. 1A and 1B: device20 comprises a filament 21 that is substantially similar to the filamentfrom which device 10 is made. However, device 20 may also comprise oneor more of a first end piece 22 residing at one end of filament 21, anda second end piece 23 residing at the opposite end of filament 21.

In the undeployed state (FIG. 2A), filtering device 20, includingend-pieces 22 and 23, may be configured to reside in the lumen of ahollow needle. Upon exteriorization from such a needle (FIG. 2B),filtering device 22 may assume a deployed shape substantially similar tothat of filtering device 10, and end-pieces 22 and 23 may assume a shape(but not required to) that is different from their shape in theundeployed state of device 20.

Reference is now made to FIG. 3A, which depicts a schematicrepresentation of end piece 23 in the undeployed state according to someembodiments. End piece 23 may comprise one or more of the following: ananchor 31, a radiopaque marker 32, an echogenic marker 33, and a bearing34. End piece 23 may also comprise a non-traumatic tip, such as aball-shaped protrusion made of metal.

Anchor 31 may comprise any means known in the art for attaching aforeign body to living tissue. For example anchor 31 may comprise aroughened surface, one or more barbs, one or more micro-barbs, one ormore hook, a hydrogel bulge configured to enlarge upon contact with anaqueous environment, or their likes. Anchor 31 may be configured tochange its shape upon transition from the undeployed state to thedeployed state of device 20 (FIG. 3B). Anchor 31 may comprise abiocompatible metal, a biocompatible polymer, a shape memory material, asuper elastic material (e.g. super elastic nitinol) or any combinationthereof.

Radiopaque marker 32 may comprise a biocompatible radiopaque material,such as gold or platinum.

Echogenic marker 33 may comprise a biocompatible echogenic material,such as tantalum. The marker 33 may comprise an echogenic coatingcomprising air micro-bubbles, cornerstone reflectors, or any other meansknown in the art to increase echogenicity. Upon transition from theundeployed state to the deployed state of device 20, marker 33 mayretain its shape. Alternatively, the shape of marker 33 may change upontransition from the undeployed to the deployed state.

Bearing 34 may comprise an axle 35 and a housing 36. Axle 35 may beconfigured to freely rotate within housing 35. Alternatively, axle 35may be configured to rotate within housing 35 with any pre-specifieddegree of friction. Axle 35 may be rigidly connected to an end offilament 21. Alternatively, axle 35 may be integral with an end offilament 21. Housing 36 may be rigidly connected to anchor 31. In thisway, upon application of torque to axle 35, the axle may rotate insidehousing 36, and housing 36 may remain substantially motionless withrespect to the tissue in which it resides.

Bearing 34 may comprise any mechanism known in the art for constrainingrelative motion between the axle and the housing to only a desiredmotion. For example, bearing 34 may comprise a plain bearing, a bushing,a journal bearing, a sleeve bearing, a rifle bearing, a rolling-elementbearing, a jewel bearing, and a flexure bearing.

End piece 22 may be the same as or different from end piece 23.Similarly to end piece 23, end piece 22 may comprise one or more of ananchor, a radiopaque marker, an echogenic marker, and a bearing.

We note that different components in each end piece need not bephysically distinct: for example, the housing of the bearing can alsoserve as an anchor, the radiopaque marker and the echogenic marker maybe one and the same, the bearing may serve to provide radiopacity orechogenicity, and so forth. To illustrate this point, reference is nowmade FIGS. 4A and 4B, which represent an embodiment of end piece 23according to the present disclosure, and to FIGS. 5A and 5B, whichrepresent an embodiment of end piece 22 according to the presentdisclosure.

FIG. 4A depicts the undeployed state of a particular embodiment of endpiece 23, according to the present disclosure. End piece 23 may comprisean external cylinder 41, prongs 45, a proximal ring 42, a distal ring43, a ball 44, and axle 35. External cylinder 41 and prongs 45 may beintegral with each other. They may be made from a shape memory orsuper-elastic alloy, such as nitinol. Upon transition of device 20 fromthe undeployed to the deployed state, prongs 45 extend outwards, therebyanchoring end piece 23 in the tissue in which it is implanted. Theproximal part of cylinder 41, proximal ring 42, and distal ring 43 maybe rigidly connected to each other to form a bearing housing 36. Rings42 and 43 can each be made from a radiopaque and or echogenic material,such as god, platinum, or tantalum. The end of filament 21 may berigidly connected to, and may be integral with, ball 44, which can bemade out of metal, a polymer, an alloy, a shape memory material, or asuper elastic material. Together, filament end 21 and ball 44 provide abearing axle 35. The axle 35 is free to rotate within housing 36 more orless around the housing's principal axis of symmetry. However, in someembodiments, rings 42 and 43 substantially prevent all other relativemotions of axle 35 with respect to housing 36. Housing 36 and axle 35together provide a bearing.

FIG. 5A depicts the undeployed state of some embodiments of end piece22, according to the present disclosure. End piece 22 may comprise anexternal cylinder 51, and prongs 52, which may be integral with thecylinder. Both the prongs and the cylinder can be made from a shapememory or super-elastic material, such as nitinol. External cylinder 51may be rigidly connected to the end of filament 21 using any knownconnection means known in the art, such as crimping, welding, soldering,gluing, and their likes. The external surface of cylinder 51 may becoated with an echogenic coating, or carry cornerstone reflectors. Inthis way, end piece 22 may comprise an anchor and an echogenic marker.However, the embodiment of end piece 22 presented in FIGS. 5A and 5Bdoes not comprise a bearing.

Reference is now made to FIGS. 6A-6E, which illustrate a system and amethod according to some embodiments of the present disclosure forproviding embolic protection according to some embodiments of thepresent disclosure. The system and method are particularly suitable fordelivering a filtering device 20 comprising at least one end pieceincorporating a bearing. The at least one end piece incorporating abearing enables torsion in filament 21 of device 20 to be controllablyreleased during device implantation, thereby providing for a controlledand robust implantation procedure.

FIG. 6A depicts a system 60 configured to implant a filtering device 20in a body vessel 61. System 60 comprises a hollow needle 62, a pusher63, and filtering device 20. Taken together, the hollow needle and thepusher are a delivery device. Hollow needle 62 has a sharp end 63configured to pierce skin 64, subcutaneous tissue 65, and body vessel 61of a patient. Needle 62 may have a needle handle 66 located at itsproximal end 67. The needle handle 66 may be rigidly connected to needle62. Pusher 63 may have a pusher handle 68 located at its proximal end.

Hollow needle 62 may have a very small inner and outer diameter. Forexample, if the maximal collapsed diameter of undeployed filteringdevice 20 is about 200 to about 400 microns, the inner diameter ofhollow needle 62 may be in the range of about 200 to about 900 microns,and the outer diameter of hollow needle 62 can be in the range of about300 to about 1000 microns. More specifically, the inner diameter ofhollow needle 62 may be in the range of about 200 to about 400 microns,and the outer diameter of needle 62 may be in the range of about 300 toabout 600 microns. Thus, the puncture holes made by hollow needle 41 ina patient's tissue may be sufficiently small (about 400 to about 800microns) as to be self-sealing.

Hollow needle 62 may be made out of any suitable biocompatible material,such as, for example, steel. Pusher 63 may also be made out of a metalsuch as steel. Handles 66 and 68 may be made out of plastic.

In the absence of external load, filtering device 20, in someembodiments, assumes the deployed shape of FIG. 2B. To transform device20 to the undeployed state, it may be stretched by applying axial forceat both its ends using a special jig (not shown). The stretched devicemay then be inserted into the lumen of needle 62 by sliding the needleover the stretched, undeployed device. Twisting device 20 before orduring insertion into needle 62 is also possible.

Both filtering device 20 and pusher 63 may be slidable within the lumenof hollow needle 62. Prior to deployment, filtering device 20 is locatedinside the lumen of needle 62 near its distal end 63. The distal end 68of pusher 63 is also located inside the lumen of hollow needle 62. Thedistal end 68 of pusher 63 is in contact with the proximal end of endpiece 22 of device 20. After deployment, as depicted in FIG. 6E,filtering device 20 may be exteriorized from hollow needle 62, and thedistal end of pusher 63 roughly coincides with distal end 63 of hollowneedle 62.

The implantation of filtering device 20 in body vessel 61 may proceed asfollows. First, a physician determines that it is desirable to implantfiltering device 20 in body vessel 61. Under the guidance of a suitableimaging modality (not shown), such as, for example, ultrasound, highresolution ultrasound, or CT scanning, or without imaging guidance atall, the operator punctures skin 64 adjacent to vessel 61 using thesharp end 63 of needle 62. Note that delivery device 60 is in theconfiguration depicted in FIG. 6A, that is, with filtering device 20housed near the distal end of hollow needle 62, in its undeployed state.The operator then carefully advances delivery device 60 through thesubcutaneous tissue, and transversely punctures vessel 61 atapproximately diametrically-opposed sites 690 and 691. The firstpuncture 690 of vessel 61 is made on its side closer to skin 64, and thesecond puncture 691 is made on the diametrically-opposite side. Thesharp end of needle 63 may then be advanced a few more millimetersinteriorly into the patient, so that end piece 23 may be exterior to thelumen of vessel 61. This situation is depicted in FIG. 6A.

Next, the operator holds pusher 63 substantially motionless whileretracting hollow needle 62 backwards, away from the patient. This canbe done with the aid of handles 66 and 68. In this way, end piece 23 ofdevice 20 is exteriorized from needle 62. It then assumes its deployedstate in the tissue proximate second puncture 691, thereby potentiallyanchoring the distal end of device 20 in the tissue. The needle may thenbe retracted until its distal end 63 roughly coincides with proximalpuncture 690. This situation is depicted in FIG. 6B.

To exteriorize the remainder of device 20 from hollow needle 62, theoperator advances pusher 63 towards the distal end 63 of needle 62 whileholding the needle still. As device 20 is exteriorized from the needle,it gradually assumes its deployed, spring-like shape-like shape. Thissituation is depicted in FIG. 6C.

In some embodiments, exteriorizing device 20 may create torque along theprincipal axis of end-piece 23. In such embodiments, it may beadvantageous for end piece 23 to comprise a bearing 34, thereby enablingthe strain (torsion) pre-existing in filament 21 to release. This mayalso prevent torsion from building up during the exteriorizationprocess. In such embodiments, the distal end of filament 21 rotates withend piece 23 as a pivot point while device 20 is exteriorized. Theoperator stops pushing the pusher once filament 21 is essentiallyexteriorized from needle 62 into the lumen of vessel 61, and end piece22 is situated, still inside the lumen of needle 62, proximate itsimplantation site. The situation is then as depicted in FIG. 6D.

In some embodiments, to complete the implantation procedure, theoperator holds pusher 63 steady while retracting needle 62 over thepusher. This causes the end piece 22 to be exteriorized at itsimplantation site and assume its deployed shape. Once the entire device20 is exteriorized and implanted in its deployed state, both needle 62and pusher 63 are exteriorized from the patient's body. This completesthe implantation procedure for some embodiments, as depicted in FIG. 6E.Note that for some embodiments, because both the filtering device 20 andhollow needle 62 are of a diameter which is sufficiently small, all ofthe holes and the punctures made in body tissues during the proceduremay be self-sealing. Therefore, the suturing or sealing of holes andpunctures thus made is unnecessary. If it is determined that one or moreadditional filtering devices should be implanted in one or moreadditional implantation sites the procedure may be performed again,essentially as described above.

The system and implantation method corresponding to embodiment 10 of thefiltering device are substantially similar to those described fordelivery device 20 and its associated method of use, as described above.Therefore, a detailed description of delivery devices and implantationprocedures corresponding to filtering device 10 is omitted.

In some embodiments, the implantation of filtering device 20 by means ofsystem 60 in a body vessel may involve making a single puncture in thevessel wall, as opposed to two roughly diametrically opposed punctures:The operator makes a single proximal puncture in the vessel wall usingneedle 62, or using distal end-piece 23, the distal end of which may besharp. The operator then places the distal tip of needle 62, or thedistal tip of end-piece 23, in the lumen of the vessel. Subsequently,the operator advances device 20 into the vessel lumen by pushing pusher63 while holding needle 62 steady, until only the proximal end-piece 22remains inside needle 62. Finally, exteriorization of device 20 fromneedle 62 is completed by, for example, retracting needle 62 whilemaintaining pusher 63 in place. Upon the completion of theexteriorization of device 20 from needle 62, end piece 23 may be locatedanywhere inside the lumen of the vessel. For example, end piece 23 mayappose the vessel wall. For example, end piece 23 may appose the vesselwall at a location roughly diametrically opposed to the puncture site.For example, end-piece 23 may partially or completely penetrate thevessel wall. For example, end-piece 23 may completely penetrate thevessel wall. Proximal end piece 22 may be located outside the lumen ofthe vessel, across the lumen of the vessel, or inside the lumen of thevessel. Typically, end piece 22 may comprise an anchor configured toprevent the migration of device 22 by securing it to the tissue of thevessel wall, or to tissue proximate the vessel wall. Upon completion ofthe exteriorization step, needle 62 and pusher 63 are withdrawn from thepatient's body, and the implantation of device 20 is complete.

Reference is now made to FIG. 7, which provides a schematic blockdiagram of some embodiments according to the present disclosure of anautomatic system for providing embolic protection according to someembodiments of the present disclosure. In some embodiments, mandatoryblocks or components have solid outlines in FIG. 7, whereas optionalblocks or components have dashed outlines. Solid lines connecting blocksrepresent information flow, power flow, or mechanical force transmissionbetween blocks. Dashed lines connecting blocks represent optionalinformation flow, power flow, or mechanical force transmission betweenblocks. Automatic system 70 may provide for a controlled and robustimplantation of filtering device 20 (or filtering device 10), and forreduced inter-operator variability.

Accordingly, system 70 comprises a power supply 71, a control unit 72,one or more driving mechanism 73, hollow needle 74, and filtering device20. Optionally, system 70 may also comprise one or more sensors 75.Taken together, power supply 71, control unit 72, one or more drivingmechanism 73, and hollow needle 74 comprise a delivery device.

The power supply 71, control unit 72, and one or more driving mechanism73, may reside in an external unit, which is external to the patient'sbody. Needle 74, filtering device 20, and optionally, one or more sensor75 may be completely or partially located inside the patient's bodyduring the device implantation procedure. The patient-externalcomponents may be housed in an ergonomic handle (not shown) and may ormay not be sterile. The patient internal components may be sterile.System 70 may be completely disposable. System 70 may also comprise bothreusable and disposable components. For example, the externally-residingcomponents may be reusable, whereas the internally residing componentsmay be disposable.

Power supply 71 may be an electrical or mechanical source of (free)energy. Power supply 71 may be a direct current source, such as abattery. Power supply 71 may also be an alternating current source.

Control unit 72 may comprise an input/output device, a centralprocessing unit, a digital memory (all not shown), and any type of ananalog or digital electronic controller (not shown), such as a computerprocessor programmed to cause any conceivable motion to filtering device20. For example, control unit 72, by means of one or more drivingmechanism 73, may cause filtering device 20 to bend, twist, rotate,translate, or any combination of such motions. The controller may be anopen loop controller, a closed loop controller, a proportionalcontroller, a proportional integral derivative controller, or any othertype of controller known in the art. Control unit 72 may store andimplement any predetermined program of filtering device motions. Controlunit 72 may optionally also receive inputs from one or more sensors 75,and implement this information in governing the motion of filteringdevice 20.

One or more driving mechanism 73 may comprise one or more motor and oneor more transmission. The one or more transmission may couple the one ormore motor to hollow needle 74 and/or filtering device 20. The one ormore driving mechanism 73 may be configured to rotate needle 74 (therebycausing some or all of filtering device 20 to rotate). Alternatively,one or more driving mechanism 73 may cause filtering device 20 to rotateby direct mechanical coupling between the driving mechanism and thefiltering device. One or more driving mechanism 73 may be configured tocause needle 74 to advance or retract. One or more driving mechanism 73may be configured to cause filtering device 20 to advance or retractwithin needle 74, or to move together with the needle such that there isno relative motion between the filtering device and the needle. One ormore driving mechanism 73 may be configured to cause filtering device 20to be exteriorized from needle 74. Mechanical coupling between one ormore driving mechanism 73 and filtering device 20 may be made by meansof a pusher, a rotating shaft, a spring, and their likes.

One or more driving mechanism 73 may comprise one or more motor. Themotor or motors may be of the following types: a DC motor, a universalmotor, an AC motor, a stepper motor, a permanent magnet motor, a brushedDC motor, a brushless DC motor, a switched reluctance motor, a corelessDC motor, a printed armature or pancake DC motor, an AC motor withsliding rotor, a synchronous electric motor, an induction motor, adoubly fed electric motor, a singly fed electric motor, and a torquemotor. Signals, which may be generated by control unit 72 according to apredetermined program, or by a program optionally configured to receivesignals from optional one or more sensor 75, may be transmitted to oneor more driving mechanism 73. One or more driving mechanism 73 may thencause filtering device 20 to move in accordance with the predeterminedprogram or sensor-signal-sensitive program, thereby achieving automaticdevice implantation.

Hollow needle 74 may be substantially similar to hollow needle 62 ofFIGS. 6A-6E. Therefore, we shall omit its detailed description here.Filtering device 20 may reside in its undeployed state inside the lumenof needle 74.

One or more optional sensors 75 may comprise one or more of: a chemicalsensor, a physical sensor, a mechanical sensor, a physiological sensor,an electrophysiological sensor, and a pressure sensor. Optional one ormore sensors 75 may be mounted on needle 74. Optional one or moresensors 75 may provide information on whether the tip of needle 74 iswithin the lumen of a vessel, such as, for example, a blood vessel, orwithin the surrounding tissue. A pressure sensor may serve this functionbecause the blood pressure (that is, the pressure inside the lumen of ablood vessel) is different from the pressure in the surrounding tissue.This information may provide extra safety: for example, control system72 may be preprogrammed to prevent the exteriorization of an end unit offiltering device 20 unless the pressure sensed is within ranges typicalfor blood pressure in the target vessel.

Optional one or more sensors 75 may sense the stage of the heart cycle.As it might be advantageous to exteriorize the filtering device 20 onlywhen the target vessel is in a relaxed state (corresponding to a heartdiastole), optional one or more sensor 75 may comprise anelectro-cardiogram (ECG) sensor.

In some embodiments, the implantation of filtering device 20 by means ofautomatic system 70 in a body vessel may proceed as follows. First, aphysician determines that it is desirable to implant filtering device 20in the body vessel. Under the guidance of a suitable imaging modality(not shown), such as, for example, ultrasound, high resolutionultrasound, or CT scanning, or without imaging guidance at all, theoperator punctures the skin adjacent to the vessel 61 using the sharpend of needle 74. The operator then carefully advances delivery device70 through the subcutaneous tissue, and transversely punctures thevessel at approximately diametrically-opposed sites. The sharp end ofneedle 74 may then be advanced a few more millimeters interiorly intothe patient, so that end piece 23 is exterior to the lumen of thevessel. Once this positioning is achieved, the operator instructscontrol unit 72 to execute a predetermined program (which optionallydepends on inputs from one or more sensor 75), which causes device 20 tobe properly exteriorized, such that the end pieces are external to thevessel lumen and the filament of device 20 is properly arranged withinthe lumen. Once the device 20 is properly exteriorized, the operatorextracts system 70 from the patient's body.

In some embodiments, the implantation of filtering device 20 by means ofautomatic system 70 in a body vessel may proceed as in the previousparagraph until the step in which the operator punctures the bodyvessel. Instead of making two substantially diametrically-opposedpunctures in the vessel wall, the operator makes a single puncture inthe vessel wall using needle 74, or using distal end-piece 23. Theoperator then places the distal tip of needle 74, or the distal tip ofend-piece 23, in the lumen of the vessel. Subsequently, the operatorinstructs control unit 72 to execute a predetermined program (whichoptionally depends on inputs from one or more sensor 75), which causesdevice 20 to be properly exteriorized. Upon the completion of theexteriorization step, end piece 23 may be located anywhere inside thelumen of the vessel. For example, end piece 23 may appose the vesselwall. For example, end piece 23 may appose the vessel wall at a locationroughly diametrically opposed to the puncture site. For example,end-piece 23 may partially or completely penetrate the vessel wall. Forexample, end-piece 23 may completely penetrate the vessel wall. Forexample, proximal end piece 22 may be located outside the lumen of thevessel, across the lumen of the vessel, or inside the lumen of thevessel. End piece 22 may comprise an anchor configured to prevent themigration of device 22 by securing it to the tissue of the vessel wall,or to tissue proximate the vessel wall.

In some embodiments, system 70 may cause device 20 to rotate, bend, ortwist in order to prevent the build-up of torsion during deviceexteriorization. In some embodiments, system 70 may cause device 20 torotate, bend, or twist in order to release torsion accumulated in thedevice.

Reference is now made to FIG. 8, which schematically represents someembodiments of a system 80 for providing embolic protection. System 80comprises a patient-external unit 81 and a patient-internal unit 82.Patient external unit 81 may be disposable or reusable. Patient-internalunit 82 may be disposable. Device 80 may be sterilizable using meansknown in the art, such as ETO sterilization, gamma ray sterilization,and their likes. Patient-internal unit 82 may reversibly connect anddisconnect from patient-external unit 81 whenever unit 81 is reusable.Such reversible connection means may comprise any known reversibleconnections means such as, for example, a screw.

Patient-external unit 81 may comprise a power supply 810, a control unit811, driving mechanisms 819, 832, and 833, gear ring 815, and bearing816, all of which may be housed in housing 834. Patient-internal unit 82may comprise needle 831 and filtering device 20. Filtering device 20 mayreside in its undeployed, substantially linear state within the lumen ofneedle 831.

Power supply 810 and control unit 811 may be substantially similar topower supply 71 and control unit 72, respectively. Therefore, theirdetailed description is omitted here.

Driving mechanism 833 may configured to advance or retract needle 831with respect to housing 834. Driving mechanism 832 is configured torotate needle 831. Driving mechanism 819 is configured to advance orretract device 20 with respect to housing 834. Bearing 816 is configuredto allow needle 831 to rotate with respect to housing 834. Gear ring 815may be configured to couple needle 831 to driving mechanisms 832 and833. Gear ring 815 may attach to the proximal end of needle 831 aroundthe circumference of needle 831.

Driving mechanism 833 may comprise a motor 818 and a shaft 817. Motor818 may be substantially similar to the one or more motors comprised inone or more driving mechanism 73. Therefore, a detailed description ofmotor 818 is omitted here. Shaft 817 may be configured to transmit thelinear (advancement/retraction) motion generated by motor 818 to gearring 815, thereby advancing or retracting gear wheel 815 (and needle 831to which gear wheel 815 may be rigidly connected) with respect tohousing 834.

Gear wheel 815 may be connected to shaft 817 in the following way: gearwheel 815 may comprise a circular groove (not shown) at its proximalend, and the tip of shaft 817 may be inserted in this groove. The shapeof the groove may be made such that its opening to the proximal face ofgear wheel 815 may be narrower than its interior. Similarly shaft 817may comprise a bulb at its distal tip, whose maximal width is largerthan the size of the opening of the groove. Thus, whenever the tip ofshaft 817 is inserted in the groove, linear motion of shaft 817 istranslated to likewise linear motion of gear wheel 815 (and needle 831)by the coupling between the shaft and the groove. However, gear wheel815 is free to rotate without hindrance from shaft 817 because the tipof shaft 817 is free to slide within the channel of the groove.

Driving mechanism 832 may comprise a motor 812, a shaft 813, and a gearwheel 814. Motor 812 may be substantially similar to the one or more ofthe motors comprised in one or more driving mechanism 73. Therefore, adetailed description of motor 812 is omitted here. Shaft 832 isconfigured to transmit the rotary motion generated by motor 812 to gearwheel 814.

Gear ring 815 and gear wheel 814 may be connected by means ofinterlocking gear teeth. Therefore, the rotation of gear wheel 814 istranslated to rotation of gear ring 815. Because gear ring 815 isrigidly connected to needle 831, rotation of gear wheel 814 translatesto rotation of needle 831.

Gear wheel 814 may be configured to slide with respect to gear ring 815in the linear (advancement/retraction) direction. In this way,rotational coupling between gear wheel 814 and gear ring 815 ispreserved regardless of the linear position of bear ring 815 (and needle831). Needle 831 may be free to rotate with respect to housing 834 bymeans of bearing 816.

Driving mechanism 819 may comprise a motor 835 and a push wire 822.Motor 835, which may be of any of the types comprised by one or moredriving mechanism 73, may comprise a stator 820 and a rotor 821. Theproximal portion of flexible push wire 822 may be rolled around rotor821. The distal end of push wire 822, which may reside in the lumen ofneedle 831, may be coupled to the proximal end of device 20. Thecoupling may be reversible. For example, disconnection of the couplingmay be realized using mechanical or electrical means as known in theart, such as, electrolysis.

Whenever motor 835 is configured to cause rotor 821 to rotate in thecounterclockwise direction, push wire 822 may then advance relative toneedle 831, and device 20 caused to advance relative to the needle.Whenever motor 835 is made to cause rotor 821 to rotate in the clockwisedirection, push wire 822 is retracted with respect to needle 831. Thismay or may not cause device 20 to also retract with respect to theneedle, depending on the type of coupling between push wire 822 and theproximal part of device 20.

Whenever needle 831 rotates with respect to housing 834, the rotationalmotion is transmitted to device 20. The transmission of rotationalmotion between the needle and the device may be realized by frictionbetween the interior walls of the needle and the device. Alternatively,the inner cross-section of the needle may have a noncircular shape (FIG.9A), and one or more of the end-pieces 22 and 23 may have aperpendicular cross-sectional shape that interlocks with the crosssectional shape of the needle lumen (FIG. 9B).

In operation, power supply 810 provides electrical or mechanical powerto control unit 811. Control unit 811 transmits power and/or signals todriving mechanisms 832, 833, and 81 according to a predetermined programstored in the control unit, or by instructions from the operator thatare transmitted to the control unit via its man machine interface. Anycombination of linear and/or rotational motions of needle 831 and/ordevice 20 with respect to external housing 834 may be implemented.

In some embodiments, the implantation of filtering device 20 by means ofautomatic system 80 in a body vessel may proceed as follows. First, aphysician determines that it is desirable to implant filtering device 20in the body vessel. Under the guidance of a suitable imaging modality(not shown), such as, for example, ultrasound, high resolutionultrasound, or CT scanning, or without imaging guidance at all, theoperator punctures the skin adjacent to the vessel using the sharp endof needle 831. The operator then carefully advances system 80 throughthe subcutaneous tissue, and transversely punctures the vessel atapproximately diametrically-opposed sites. The sharp end of needle 831may then be advanced a few more millimeters interiorly into the patient,so that end piece 23 is exterior to the lumen of the vessel. Once thispositioning is achieved, the operator instructs control unit 811 toexecute a predetermined program (which optionally depends on inputs fromone or more sensor), which causes device 20 to be properly exteriorized,such that the end pieces are external to the vessel lumen and thefilament of device 20 is properly arranged within the lumen. Once thedevice 20 is properly exteriorized, the operator extracts system 80 fromthe patient's body.

In some embodiments, the implantation of filtering device 20 by means ofautomatic system 80 in a body vessel may proceed as in the previousparagraph until the step in which the operator punctures the bodyvessel. Instead of making two substantially diametrically-opposedpunctures in the vessel wall, the operator makes a single puncture inthe vessel wall using needle 831, or using distal end-piece 23, whichmay comprise a sharp tip. The operator the places the distal tip ofneedle 831, or the distal tip of end-piece 23, in the lumen of thevessel. The operator then instructs control unit 810 to execute apredetermined program (which optionally depends on inputs from one ormore sensor), which causes device 20 to be properly exteriorized. Uponthe completion of the exteriorization step, end piece 23 may be locatedanywhere inside the lumen of the vessel. For example, end piece 23 mayappose the vessel wall. For example, end piece 23 may appose the vesselwall at a location roughly diametrically opposed to the puncture site.For example, end-piece 23 may partially or completely penetrate thevessel wall. For example, end-piece 23 may completely penetrate thevessel wall. For example, proximal end piece 22 may be located outsidethe lumen of the vessel, across the lumen of the vessel, or inside thelumen of the vessel. Typically, end piece 22 may comprise an anchorconfigured to prevent the migration of device 22 by securing it to thetissue of the vessel wall, or to tissue proximate the vessel wall.

In some embodiments, system 80 may cause device 20 to rotate, bend, ortwist in order to prevent the build-up of torsion during deviceexteriorization. In some embodiments, system 80 may cause device 20 torotate, bend, or twist in order to release torsion accumulated in thedevice.

In some embodiments, a system similar to 80 is feasible, in which theneedle does not rotate but device 20 is free to rotate within theneedle. Such a delivery device need not have a bearing 816 and a drivingmechanism 832. Instead, a different driving mechanism is configured torotate device 20 inside the lumen of needle 831 by rotating pusher 822inside the needle and rotationally coupling the pusher to device 20.

Systems 70 and/or 80 may be used to deliver all monofilament implantsthat have a substantially linear undeployed state and a bent and/ortwisted deployed state. Such devices, including vessel occluders,stents, drug delivery platforms, radiation delivery platforms, PFOoccluders, Left Atrial Appendage Occluders, and their likes, aredescribed in Provisional Patent Application 61/708,273 to Yodfat andShinar, which is incorporated herein by reference. All monofilamentdevice embodiments described in 61/653,676 and also in ProvisionalPatent Applications 61/693,979 and 61/746,423 to Shinar and Yodfat, maypossess end-pieces such as 22 and 23 of the present ProvisionalApplication.

Reference is now made to FIGS. 10A and 10B, which depict a side view anda cross-sectional view of device 20 in operation. Device 20 is implantedin body vessel 80 such that its north-south axis is substantiallyperpendicular to the principal axis of symmetry of vessel 80. Embolus 81may be filtered by device 20 because the spacing 6 between consecutivewindings of the device is smaller than the size of the embolus. Theembolus may thus filter by size exclusion.

It is understood that monofilament filtering devices according to someembodiments of the present disclosure are possible in which, in thedeployed state, each end of the filament may either reside inside thelumen of a body vessel, in the wall of the vessel, or exteriorly to thewall of the vessel. For example, a device in which the proximal endresides entirely within the lumen and the distal end resides exteriorlyto the vessel is possible. A device in which both ends reside in thevessel wall without penetrating the vessel's exterior wall is possible.In this way, for each end all different combinations of penetrationdepths (in-lumen, in-wall, exterior to wall) are possible.

It is understood that monofilament filtering devices according to someembodiments of the present disclosure are possible in which, in thedeployed state, the proximal end of the monofilament extends exteriorlyfrom the patient's skin, or is implanted subcutaneously immediatelybelow the patient's skin. Such devices are particularly suited fortemporary usage, in which it is desired to retrieve the device shortlyafter a temporary embolus-enticing cause, such as surgery orminimally-invasive procedure, is removed.

Although the embodiments of the present disclosure have been hereinshown and described in what is conceived to be the most practical way,it is recognized that departures can be made from one and/or another ofthe disclosed embodiments and are within the scope of the presentdisclosure, which is not to be limited to the details described herein.The following exemplary claims aid in illustrating an exemplary scope ofat least some of the embodiments disclosed herein.

We claim:
 1. A monofilament filtering device (MFD) implantation system for implanting a MFD within a human blood vessel comprising: an MFD; a housing; a power supply; a control unit; at least one of a geared driving mechanism and a motorized driving mechanism; and a needle comprising a hollow lumen, a proximal end, and a distal end, wherein the needle is configured to receive the MFD in an undeployed state, wherein the MFD is configured for both an undeployed and a deployed state after implantation within a blood vessel including a helical portion, the MFD is exteriorized from the needle by the operation of the driving mechanism, and after implantation, at least the helical portion is within the blood vessel.
 2. The system of claim 1, wherein the driving mechanism is configured to rotate, bend, or twist the MFD.
 3. The system of claim 1, wherein the driving mechanism is configured to advance or retract the MFD.
 4. The system of claim 1, wherein the driving mechanism is configured to advance or retract the needle.
 5. The system of claim 1, further comprising one or more sensors.
 6. The system of claim 5, wherein the at least one sensor is mounted on the needle.
 7. The system of claim 5, wherein the at least one sensor comprises a pressure sensor.
 8. The system of claim 1, wherein the housing, the power supply, the control unit, and the driving mechanism reside in a patient-external unit.
 9. The system of claim 8, wherein the patient-external unit is disposable.
 10. The system of claim 8, wherein the patient-external unit is reusable.
 11. The system of claim 8, wherein the needle and the MFD comprise a patient-internal unit.
 12. The system of claim 11, wherein the patient-external unit and the patient-internal unit are reversibly connected.
 13. The system of claim 1, wherein the power supply is electrical and/or mechanical.
 14. The system of claim 1, wherein the power supply is a direct current source or an alternating current source.
 15. The system of claim 1, wherein the control unit comprises one or more of: an interface, an input/output device, an analog or digital electronic controller, and a computer processor.
 16. The system of claim 1, further comprising at least one of a pusher and a rotor.
 17. The system of claim 16, wherein the driving mechanism is configured to move at least one of the pusher, the needle and the MFD so as deploy the MFD into the vessel.
 18. The system of claim 16, wherein the pusher configured to push or otherwise move at least the MFD relative to the needle. 